Comparison of Awakening Versus Bedtime Dosing of Ramipril in Subjects With Essential Hypertension
NCT00473174
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- Essential hypertension
- Severe hypertension.
- Secondary hypertension.
- Grade III/IV hypertensive retinopathy.
- Type 1 diabetes.
- Cerebrovascular or cardiovascular event during the last 12 months prior to inclusion.
- Pregnant or lactating females.
- History of malignancy within the past five years.
- Shift workers.
- Obstructive sleep apnea.
- Use of disallowed concomitant medication.
- Intolerant to ABPM.
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Descriptive Information | ||||
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Brief Title ICMJE | Comparison of Awakening Versus Bedtime Dosing of Ramipril in Subjects With Essential Hypertension | |||
Official Title ICMJE | A Prospective, Randomized, Open Label, Blinded-endpoint Study to Compare Awakening Versus Bedtime Administration of 5-10 mg Ramipril in Terms of Systolic Blood Pressure Lowering Determined by ABPM in Subjects With Mild-to-moderate Essential | |||
Brief Summary | This prospective chronotherapy trial will investigate the potential differing efficacy of ramipril in doses from 5 to 10 mg/day when administered, as a monotherapy either upon awakening from nighttime sleep or at bedtime, to diurnally active patients with grade 1 or 2 essential hypertension, who will be evaluated by 48-hour ABPM before and after pharmacologic intervention. The benefits from this trial may be extremely important, taking into account
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Detailed Description | Several attributes of the cardiovascular system, including blood pressure (BP) and heart rate (HR), are characterized by predictable changes during the 24 hours for the most part in synchrony with the rest-activity cycle. During the past two decades specific features of the 24-hour BP pattern have been assessed as potential sources of injury to target tissues and as triggers of cardiac and cerebrovascular events in hypertensive patients. A growing number of studies indicate the reduction of the normal 10 to 20% sleep-time BP decline (non-dipper pattern) is associated with elevated risk of end-organ injury, particularly to the heart (left ventricular hypertrophy and myocardial infarct), brain (stoke) and kidney (albuminuria and progression to end-stage renal failure). Accordingly, there is growing interest in how to tailor the treatment of hypertensive patients according to their circadian BP pattern. Clinical studies demonstrated a different effect of the ACEIs benazepril, enalapril, perindopril, quinapril, spirapril, and trandolapril when dosed in the morning versus the evening. A small trial on 33 patients with essential hypertension showed that a low dose of 2.5 mg/day ramipril more effectively reduced daytime BP when it was administered in the morning and more effectively reduced nighttime BP when it was administered in the evening. In the HOPE (Heart Outcomes Prevention Evaluation) study patients in the active treatment group received ramipril at bedtime. Results from a small substudy, in which hypertensive patients were evaluated with 24-hour ambulatory BP monitoring (ABPM), showed a marked BP reduction particularly during nighttime sleep, thereby reducing the prevalence of non-dippers. The authors concluded that the effects on cardiovascular morbidity and mortality seen with ramipril in the HOPE study may relate to its improved effect (i.e., increase in the diurnal/nocturnal BP ratio) on the non-dipping BP patterns. In keeping with the documented administration-time dependent effects on BP regulation of other ACEI, this prospective chronotherapy trial will investigate the potential differing efficacy of ramipril in doses from 5 to 10 mg/day when administered, as a monotherapy either upon awakening from nighttime sleep or at bedtime, to diurnally active patients with grade 1 or 2 essential hypertension, who will be evaluated by 48-hour ABPM before and after pharmacologic intervention. The benefits from this trial may be extremely important, taking into account 1) the high prevalence of non-dipping among patients with essential hypertension, 2) the need for a proper 24-hour BP control with particular emphasis on the regulation of nighttime resting BP mean, and 3) the lacking information on the administration-time dependent effects on BP of ramipril, a widely used ACEI in doses of 5-10 mg/day. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Hypertension | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Hermida RC, Ayala DE. Chronotherapy with the angiotensin-converting enzyme inhibitor ramipril in essential hypertension: improved blood pressure control with bedtime dosing. Hypertension. 2009 Jul;54(1):40-6. doi: 10.1161/HYPERTENSIONAHA.109.130203. Epub 2009 May 11. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 120 | |||
Original Estimated Enrollment ICMJE | 200 | |||
Actual Study Completion Date ICMJE | December 2008 | |||
Actual Primary Completion Date | December 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Spain | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00473174 | |||
Other Study ID Numbers ICMJE | HYCCRA-2006/01 Eudract-2006-006107-37 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Ramon C. Hermida, University of Vigo | |||
Study Sponsor ICMJE | University of Vigo | |||
Collaborators ICMJE | King Pharmaceuticals is now a wholly owned subsidiary of Pfizer | |||
Investigators ICMJE |
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PRS Account | University of Vigo | |||
Verification Date | September 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |